Since Dr. Halstead first introduced surgical gloves so as to protect the surgeon from irritating disinfectants, patients have been adversely affected by reactions from the gloving agents. A gloving agent is a lubricating medium applied to the inside and outside of the surgeon's glove or other device to prevent sticking in storage and to help the user to install the glove, condom, drain, catheter tube or other medical device.
Water was initially used to ease the donning of rubber gloves but because it is a poor lubricant, water was abandoned as a gloving agent in the 1930's and replaced with talc powders. These talc powders in turn were found to cause severe foreign body reactions in the patients such as peritonitis, chronic fistulae and poor wound healing. By the late 1940's cornstarch was substituted for talc. In 1956 the first cases of starch peritonitis in humans were described in numerous reports. In the 1960's glove manufacturers introduced a rice starch derivative hoping that it would cause fewer problems but it was quickly removed from the market when it was associated with an increased incidence of peritonitis. Presently, throughout the world, most commercially available surgical gloves contain a cornstarch derivative for lubrication. Gloving powders, lotions and creams also generally contain cornstarch. Cases of pelvic peritonitis have been reported following the repeated use of condoms which contained starch powder. Starch may be responsible for extraperitoneal inflammatory reactions and the postpericardiotomy syndrome.
Although the medical profession understands that talc and starch lubricants cause severe reactions and the issue is discussed in many United States patents such as U.S. Pat. Nos. 3,728,739 and 3,872,515, the commercially available gloves, condoms, drains, catheters and tubes utilize starch in some form as a lubricant coating. On the other hand, the coating disclosed herein is readily absorbed by tissue without deleterious reactions.